Pain in Trans Femoral and Trans Tibial Amputees (AMPUPHANTOM)
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|ClinicalTrials.gov Identifier: NCT03789435|
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : August 21, 2019
Phantom limb is difficult to manage and has a significant impact on the patient's quality of life. At present, the scientific evidence shows that the infusion of local anesthetics with epidural and perineural catheters in the perioperative phase correlates with good pain control in the immediate post-operative, expressed in terms of reduced demand for opiates by the patient undergoing amputation. of lower limb. Few are studies that highlight the effectiveness of such treatments in the medium and long-term prevention of phantom limb syndrome.
The study aims to evaluate the incidence in the medium term of the phantom limb in trans femoral and trans tibial amputees and the possible relationship with the use of adequate pre and perioperative analgesia using peridural and peripheral nerve catheters. The results of the study could provide indications about the need to modify both the perioperative analgesic therapy protocol and also rehabilitation for lower limb amputation surgery in order to reduce the prevalence of phantom limb syndrome with consequent improvement in quality of life.
|Condition or disease||Intervention/treatment|
|Lower Limb Amputation Above Knee Lower Limb Amputation Below Knee||Diagnostic Test: Questionnaire|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||170 participants|
|Target Follow-Up Duration:||7 Days|
|Official Title:||Medium-term Incidence Study of Phantom Limb Syndrome in Trans Femoral and Trans Tibial Amputated Patients|
|Actual Study Start Date :||March 7, 2019|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Patients underwent trans-tibial and trans-femoral amputation of any etiology at the Rizzoli Orthopedic Institute from 2015 to 2017 with the presence of analgesia data for surgery in a computerized record (SIR, Rizzoli information system). A questionnaire for the detection of residual limb pain will be administrate to all the survivors.
Diagnostic Test: Questionnaire
A questionnaire from which the session dedicated to the evaluation of the stump pain, the phantom limb and the sensation of the phantom limb has been extracted will be administered: this is the Prosthetic Evaluation Questionnaire (PEQ) validated in Italian by Ferrero et al. 2005.
In the questionnaire sent to patients will be asked also for anthropometric data (weight, height) in addition to the characteristics of the worn prosthesis and if they have followed a period of rehabilitation.The time of use of the prosthesis will be evaluated through the Houghton Scale of Prosthetic Use in People with Lower- Extremity Amputations (19)
- Mid-term incidence (1 to 3 years) of pain in the stump or phantom limb and phantom limb sensation in amputated trans femoral and trans tibial patients treated at IOR from 2015 to 2017. [ Time Frame: 7 days ]Data will be obtained by means of questionnaire sent to patients.
- Evaluation of the type of anesthesia and perioperative analgesic treatment with peripheral nerve block effected and of the use of the prosthesis to evaluate possible relations with the presence and the entity of the phantom limb. [ Time Frame: 7 days ]Anesthesia data will be retrieved from patient records.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789435
|Contact: Maria Grazia Benedetti, MD||6366236 ext +firstname.lastname@example.org|
|IRCCS-Istituto Ortopedico Rizzoli||Recruiting|
|Bologna, Italy, 40136|
|Contact: Maria Grazia Benedetti, MD 6366236 ext +39051 email@example.com|
|Principal Investigator:||Maria Grazia Benedetti||IRCCS-Istituto Ortopedico Rizzoli|